Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 10
- 主要终点
- Urinary incontinence score assessed with ICIQ-SF questionnaire
研究概览
简要总结
Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.
Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.
详细描述
Justification:
Pelvic floor disorders lead to handicap and medical care consumption. Pregnancy and delivery are the main etiologies. Pelvic floor exercises are proposed for prevention and may reduce immediate postpartum incontinence but we do not know if this preventive effect persists at 1 year.
Principal criteria:
- Urinary incontinence score at 12 months post-partum (ICIQ-SF)
Secondary criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous
- •aged 18 years or more
- •pregnant between 20 and 28 weeks
- •French language reader
排除标准
- •No medical insurance
- •multiple or pathologic pregnancy
- •Previous pelvic floor exercises with a physiotherapist less than 6 months before pregnancy
结局指标
主要结局
Urinary incontinence score assessed with ICIQ-SF questionnaire
时间窗: one year post partum
次要结局
- Urinary incontinence prevalence(pregnancy end, 2 and 12 months post partum)
- Other pelvic floor symptoms (anal incontinence, pain, sexual troubles)(pregnancy end, 2 and 12 months post partum)
- Genital prolapse assessed by POP-Q(2 months post-partum)
- Pelvic floor strength(2 months post partum)
- Quality of life (Euroquol 5D, Contilife)(at delivery, 2 and 12 months post partum)
- pad-test(2 months post partum)
- need to medical care(12 months post partum)